Fipralone Duo 268 mg/80 mg Spot-on Solution for Large Dogs

Shampooing or immersion of the animal in water directly after treatment may reduce the
duration of activity. The veterinary medicinal product remains effective against fleas for 5
weeks when the dog is shampooed at monthly intervals after treatment. If the dog requires
shampooing, it is better to do so before treatment.
Water immersion repeated on two occasions post treatment did not affect adulticidal
efficacy against fleas nor the efficacy related to the prevention of the development of flea
eggs into adult fleas.
The influence of water immersion or shampooing of the dog on the efficacy of the
veterinary medicinal product against ticks has not been evaluated.
At the beginning of the control measures, in the case of an infestation, the animal's basket,
bedding and regular resting areas such as carpets and soft furnishings should be treated,
with a suitable insecticide and vacuumed regularly.
To reduce environmental flea challenge, all animals living in the same household should
also be treated with a suitable flea control product.
The veterinary medicinal product does not prevent ticks from attaching to animals.
Transmission of infectious disease by ticks cannot be completely excluded if conditions
are unfavourable.
Immediate efficacy has been demonstrated against , indicating that ticks of
this species are likely to be killed within 48 hours of product application. If
reticulatus or ticks are present when the veterinary medicinal
product is applied, these ticks may not be killed within the first 48 hours.
Once dead, ticks will often drop off the animal. Any remaining ticks should be carefully
removed, ensuring that their mouth parts are not left within the skin.

Special precautions for safe use in the target species:
For external use only.
Animals should be weighed accurately prior to treatment.
In absence of safety data, the veterinary medicinal product should not be used in puppies
less than 10 weeks old and/or weighing less than 2 kg.
Care should be taken to avoid the content of the pipette coming into contact with the eyes
or mouth of the recipient dogs. In particular oral uptake due to the licking of the application
site by treated or in-contact animals should be avoided.
Do not apply the veterinary medicinal product on wounds or damaged skin.
In the absence of additional safety studies, do not repeat the treatment at intervals of less
than 4 weeks.
The use of the veterinary medicinal product has not been studied in sick and debilitated
dogs.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
The veterinary medicinal product may cause neurotoxicity.
The veterinary medicinal product may be harmful if swallowed.
Avoid ingestion including hand to mouth contact.
Do not smoke, drink or eat during application.
In case of accidental ingestion, seek medical advice immediately and show the package
leaflet or the label to the physician.
This veterinary medicinal product can cause eye and mucous membrane irritation.
Avoid contact with skin, eye and mouth, including hand to eye contact.
In case of accidental skin or eye contact, immediately and thoroughly flush with water. If
skin or eye irritation persists, seek medical advice immediately and show the package
leaflet or the label to the physician.
Wash hands after use.
Treated animals should not be handled until the application site is dry, and children should
not be allowed to play with treated animals until the application site is dry. It is therefore
recommended that animals are not treated during the day, but should be treated during the
early evening, and that recently treated animals should not be allowed to sleep with
owners, especially children.
Keep the pipettes in the original packaging until ready for use and dispose of used pipettes
immediately.
Special precautions for the protection of the environment:
Fipronil and pyriproxyfen may adversely affect aquatic organisms. Dogs should be
prevented from accessing streams and rivers for 48-hours following treatment (see also
section 5.5).
Other precautions:
The veterinary medicinal product may have adverse effects on painted, varnished or other
household surfaces or furnishings. Allow the application site to dry before permitting
contact with such materials.